The present invention relates to an implantable device for promoting fusion between two adjacent bony structures and a method of inserting the same. More particularly, the invention relates to an expandable fusion cage that may be inserted, in a reduced size configuration, into an intervertebral space and expanded after insertion to provide a desired size. While the device according to the present invention may have application in other areas of the body, the present invention is preferably utilized for vertebral interbody fusion.
There have been an extensive number of attempts to develop an exceptional intradiscal implant that could be used to replace a damaged disc and yet maintain the stability of the disc interspace between adjacent vertebra, at least until complete arthrodesis is achieved. These “interbody fusion devices” have taken many forms. For example, one of the more prevalent designs takes the form of a cylindrical implant. These types of implants are presented by the patents to Bagby, U.S. Pat. No. 4,501,269; Brantigan, U.S. Pat. No. 4,878,915; Ray, U.S. Pat. Nos. 4,961,740 and 5,055,104; and Michelson, U.S. Pat. No. 5,015,247. In the cylindrical implants, the exterior portion of the cylinder can be threaded to facilitate insertion of the interbody fusion device, as represented by the Ray, Brantigan and Michelson patents. In the alternative, some of the fusion implants are designed to be pounded into the intradiscal space. This type of device is represented by the patent to Brantigan.
Interbody fusion devices can be generally divided into two basic categories, namely solid implants and implants that are designed to permit bone in-growth. Solid implants are represented by U.S. Pat. Nos. 4,879,915; 4,743,256; 4,349,921; and 4,714,469. The remaining patents discussed above include some aspect that allows bone to grow across the implant. It has been found that the devices that promote natural bone in-growth achieve a more rapid and stable arthrodesis. The device depicted in the Michelson patent is representative of this type of hollow implant which is typically filled with a bone growth inducing substance to promote bone growth into and through the device. This implant includes a plurality of circular apertures which communicate with the hollow interior of the implant, thereby providing a path for tissue growth between the vertebral end plates and the bone growth material within the implant. In preparing the intradiscal space, the end plates are preferably reduced to bleeding bone to facilitate the tissue in-growth. During fusion, the metal structure provided by the Michelson implant helps maintain the patency and stability of the motion segment to be fused. In addition, once arthrodesis occurs, the implant itself serves as a sort of anchor for the solid bony mass.
One problem that is not addressed by the above prior devices concerns maintaining and restoring the normal anatomy of the fused spinal segment. Naturally, once the disc is removed, the normal lordotic or kyphotic curvature of the spine is eliminated. With the prior devices, the need to restore this curvature is neglected. For example, adjacent vertebral bodies may be reamed with a cylindrical reamer that fits the particularly implant. In some cases, the normal curvature is established prior to reaming and then the implant inserted. However, this over-reaming of the posterior portion is generally not well accepted because of the removal of load bearing bone of the vertebrae and because it is typically difficult to ream through the posterior portion of the lower lumbar segment where the lordosis is the greatest. In most cases using implants of this type, no effort is made to restore the lordotic curvature so that the cylindrical implant is likely to cause a kyphotic deformity as the vertebrae settles around the implant. This phenomena can often lead to revision surgeries because the spine becomes imbalanced.
In each of the above-listed patents, the transverse cross-section of the implant is substantially constant throughout its length and is typically in the form of a right circular cylinder. Other implants have been developed for interbody fusion that do not have a constant cross-section. For instance, the patent to McKenna, U.S. Pat. No. 4,714,469 shows a hemispherical implant with elongated protruberances that project into the vertebral end plate. Further, U.S. Pat. No. 5,669,909 to Zdeblick et al., shows a truncated conical implant adapted to be threadedly received in the intervertebral space. However, these devices require an opening at least as large as the largest segment of the device. The requirement for such a relatively large opening may limit the use of such devices, particularly where access to the spine is limited due to obstructing vessels and neurological structures.
Still further implants have been developed that provide the ability to adjust the size of the implant after insertion. U.S. Pat. Nos. 5,665,122 to Kambin, 5,554,191 to LaHille et al., and 5,653,763 to Errico et al. disclose implants which provide at least some degree of adjustability of the height of the implant to restore lordosis. However, these implants do not allow the device to be easily and securely inserted into a disc space and the internal expansion mechanism limits the ability to pack the interior with a large amount of bone in-growth material.
In view of the limitations of the prior devices, there remains a need for an expandable interbody device capable of stabilizing the spine in a manner comparable to interbody implant designs presently in use, and at the same time providing a mechanism for restoring normal lordosis of the spine. After expansion, the device should have an internal cavity adapted to receive bone graft or bone substitute to encourage bone growth through the expanded device.